Download Guidelines for Validation &Qualification, including Change Control

9. Data Processing and Storage
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10
9.11
9.12
9.13
9.14
9.15
The equipment must be capable of interfacing with the laboratory computer system
i.e. insert system.
The interface must be bi-directional.
The Tenderer should provide details of when the proposed interface will be
operational and what functionality will be available for go live
Where necessary it must be possible to use the equipment in a stand-alone mode.
Automatic reconnection to the host computer should be available and transmission
of results from stand-alone running
State the capability of the equipment to continue to process samples and generate
reports during periods of unavailability of the computer host system and the
mechanism for doing this.
The requirement for a data manager, either supplied as original equipment or as an
adjunct to the equipment must be stated.
The precise specification and functionality of such a data manager must be clearly
stated.
Provide details of the data handling and management capabilities of the system
including inputting of any additional tests and storage facilities/capacity for patient
records.
If the equipment proposed has several linked analysers it must be possible for the
other analysers to continue operating if one or more of the analysers are inoperable for whatever reason.
Stored data must be easily retrievable.
A full audit trail must be available of all tests performed including QC. Please state
what information is stored and is retrievable.
A pictorial representation of all tests performed must be stored.
Please state the format that the audit trail information and pictures will be stored
and what capacity of data/pictures can be stored.
There should be a facility to operate and monitor the analysers remotely using a
handheld Wi-Fi device.
10. Maintenance
10.1
10.2
10.3
Routine maintenance must be able to be performed by the BMS staff.
The daily, weekly and yearly maintenance procedures must be described.
The quantity, frequency and duration of preventative maintenance visits per
annum must be stated.
10.4 Maintenance contracts available must be described along with the guaranteed
response times for callouts.
10.5 State the support available at night, at weekends and public holidays.
10.6 The times during which technical support is available must be stated.
10.7 Fully detailed operator manual must be provided in English.
10.8 Please state the level of “self-help” available from the manuals.
10.9 Please state whether on-line manuals are available.
10.10 Modem links for remote access for problem solving should be available.
10.11 Please provide details of the locality of engineers and spare parts relative to the
Authority‟s normal place of business.
10.12 A guarantee must be provided that the proposed equipment will be supported and
spares available for the period.
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